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Dockets Management Branch

The Food and Drug Administration
Department of Health &Human Services, Rm. 1-23
12420 Parklawn Dr.
Rockville, MD 20857
Re: 99P-1340/U l- Petition to Have Efmzity MU cleparfirm d&%&?“M’i~~ran&!ff’~ 2 ;f)2 :@
Dear Sir or Madam:
In May 1999, the Environmental Health Network (EHN) submitted the above petition to have Calvin Klein’s
Efemify eau de parfum declared “misbranded.” I am writing because I fully support this petition and request
that the FDA give it careful attention with regard to your regulations 21CFR Sec. 740.1,21CFR Sec. 740.2, and
21CFR Sec. 740.10. Regulation 21CFR Sec. 740.10 states:
Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately sub-
stantiated for safety prior to marketing. Any such ingredient or product whose safety is not adequately
substantiated prior to marketing is misbranded unless it contains the following conspicuous statement on
the principal display panel:
‘Warning - The safety of this product has not been determined.”
As the petition shows, Eternity contains toxic ingredients and ingredients whose safety have not been substan-
tiated. There is no warning label on its packaging.
We all have a right to know the status of safety testing of the ingredients in products such as Efemity so that
we can protect ourselves and our families from toxic chemicals that may cause health problems. Most people
are not aware that most fragrance materials have only limited safety testing. They wrongfully assume these
products are safe to use in any setting and are surprised when people complain.
Like tobacco smoke, the harmful chern)cals currently used in these products may affect the health of many
people, including: people with asthma, cpemical sensitivities, chronic fatigue, and other environmental illness-
es Children are particularly vulnerable t toxic chemicals found in products purchased and used by their
parents, caregivers and teachers. When I %Em exposed to fragrance products I can experience any of the follow-
ing svmptoms
i based upon the chemical f)agrance product I encounter:
J! anaphylaxis/shock 0 double vi$on 3 incoherence 0 nauqea
J anxiety, restlessness g ear pain ,$!l incontinence 0 nose. bleeds
$ asthma 0 eczema 3 irritability ia rashes
y breathing difficulty 0 eyes, watery or dry 0 joint aches 0 seizures
3 bronchitis ~3 fatigue 3 laryngitis 0 short-term mem. loss
El can’t concentrate 0 flushing 0 lethargy 0 sinusitis
$4. coughing headaches D lymph nodes swell IZ sneezing
Y
t3 depression 0 heart beat irregularity 0 mood swings ti sores, skin/mouth
d disorientation 0 hives g muscle pain/weakness 0 swal-‘owing difficulty
0 dizziness Cl hypertension *, nasal congestion SF tinnitus
2 other:
Please act on behalf of the millions of people who have suffered physical illness and injury resulting from
fragrance exposure at work, at school and in social settings. These toxic chemicals act as powerful barriers to
people disabled by asthma and chemicallsensitivities. Toxic chemicals in fragrances have already ruined
countless lives. Thank you.
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Dockets Management Branch
The Food and Drug Administration
Department of Health &Human Services, Rm. l-23
12420 Parklawn Dr. - _.
Rockville, MD 20857

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THE NEW REACTOR May 1June 1999